Private Label Spf 50 80 Min Water Resistant

Private Label Spf 50 80 Min Water Resistant
SPL v4
SPL
SPL Set ID 8849fa88-24c8-410d-b16e-60da38288f98
Route
TOPICAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 g) Octisalate (50 g) Zinc Cation (165 g)
Inactive Ingredients
Water Sodium Hydroxide Edetate Disodium Glycerin Sodium Chloride Phenoxyethanol Ethylhexylglycerin Octyldodecyl Neopentanoate C15-19 Alkane Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Sorbitan Olivate Dimethicone Tocopherol Disteardimonium Hectorite Polyglyceryl-2 Isostearate Polyglyceryl-6 Polyricinoleate Gluconolactone Sodium Benzoate Calcium Gluconate Saccharide Isomerate Citric Acid Monohydrate Sodium Citrate Hydrogenated Polybutene (1300 Mw) Gossypium Hirsutum Leaf Glyceryl Monobehenate .alpha.-tocopherol Acetate Xanthan Gum Lecithin, Soybean Pullulan Betasizofiran Silicon Dioxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01
Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Medication Information

Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Homosalate 10.0% Sunscreen

Octisalate 5.0%

Zinc Oxide 16.5% Sunscreen

Inactive Ingredients

C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water

Other Safety Information

Protect this product from excessive heat and direct sun.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN   

Structured Label Content

Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Labeling

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Questions?

Call toll free 1-866-416-2366

Active Ingredients

Homosalate 10.0% Sunscreen

Octisalate 5.0%

Zinc Oxide 16.5% Sunscreen

Inactive Ingredients

C15-19 Alkane, Calcium gluconate, citric acid, dimethicone, disodium EDTA, disteardimonium hectorite, ethylhexylglycerin, gluconolactone, Gossypium hirsutum (cotton) extract, glycerin, glyceryl behenate, hydrogenated polyisobutene, lecithin, octyldodecyl neopentanoate, phenoxyethanol, polyglyercyl-2 isostearate, polyglyceryl-6 polyricinoleate, polyhydroxystearic acid, polysilicone-11, pullulan, saccharide isomerate, sclerotium gum, silica, sodium benzoate, sodium chloride, sodium citrate, sodium hydroxide, sodium olivate, tocopherol, tocopheryl acetate, triethoxycaprylysilane, xanthan gum, water

Other Safety Information (Other safety information)

Protect this product from excessive heat and direct sun.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN   

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.779904 · Updated: 2026-03-14T23:01:50.647319